Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence (EMERALD)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Renal Cancer

Treatments: Procedure: Robot assisted partial nephrectomy with renal artery clamping; Procedure: Robot assisted partial nephrectomy super-selective clamping

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT03679572

38RC17.142

Details and patient eligibility

About

Patients with renal cancer are commonly treated by robot-assisted partial nephrectomy. Renal artery clamping is commonly required inducing kidney ischemia during surgery. It impacts parenchymal and renal function. This study aims to compare a new surgical procedure in order to reduce ischemia effect and preserve renal function after partial nephrectomy for renal tumour.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• candidate for a robot-assisted partial nephrectomy for renal tumour
• patient affiliated to social security
• signature of the informed consent

Exclusion criteria

• proven or suspected allergy to the indocyanine green
• coagulation disorder contraindicating robot assistance in the partial nephrectomy
• medical pathology contraindicating pneumo-peritoneum
• multiple tumors
• horseshoe kidney
• exclusion period of another interventionnal study
• protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Robot assisted partial nephrectomy super-selective clamping

Experimental group

Description:

The Da Vinci robot (device) allows to use near-infrared fluorescence in order to clamp precisely the branches of the vascularization for the partial nephrectomy. The healthy parenchyma ischemia is avoided.

Treatment:

Procedure: Robot assisted partial nephrectomy super-selective clamping

Robot assisted partial nephrectomy with renal artery clamping

Active Comparator group

Description:

The partial nephrectomy with robotic assistance is performed using a renal artery. It's the conventional method.

Treatment:

Procedure: Robot assisted partial nephrectomy with renal artery clamping